Effects of Training Frequency on Patellofemoral Pain Rehabilitation.

NCT06808386 | Enrolling By Invitation DMC

• 1 other identifier: 84694624.0.0000.5511
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to determine the optimal frequency of exercise therapy for improving pain, function, and quality of life in participants with patellofemoral pain. The main questions it aims to answer are: Does exercising twice a week provide the same benefits as exercising three times a week for individuals with patellofemoral pain? What are the optimal dosage, volume, and weekly exercise frequency for treating patellofemoral pain? The investigators will compare two groups of participants: one group of participants receiving exercise therapy twice a week and another group receiving exercise therapy three times a week. Both groups will follow the same exercise protocol targeting the muscles of the hip and knee joints. Participants: 84 volunteers (both male and female) with patellofemoral pain Physically active individuals aged between 18 and 40 years Interventions: Participants will be randomly assigned to one of two groups Both groups will perform the same exercises for hip and knee muscle strengthening Group A will exercise three times per week Group B will exercise two times per week The intervention will last for six consecutive weeks Assessments: Participants will be evaluated at the following time points: Before the intervention After the 4th and 6th week of intervention 6 months and 1 year after the end of the intervention The primary Outcome Measure will be pain intensity. Secondary Outcome Measure: Anterior knee pain during daily activities Kinesiophobia Pain-related self-efficacy Chronic pain-related self-efficacy Catastrophizing Muscle strength 3D Movement analysis Data Analysis: The investigators will use an intention-to-treat analysis, which means that all participants will be included in the study, regardless of whether they completed the treatment as planned. Appropriate statistical tests will be used to compare differences within and between the two groups, considering the time points and group factors. A 5% significance level will be adopted, which means there is a 5% chance that the results are due to random variation rather than the treatment effect.

Conditions

Anterior Knee Pain

Keywords

Patellofemoral Pain; Exercise Therapy; Dose-Response; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Visual Analog Pain Scale: This scale aims to quantify the intensity of pain experienced by the patient. The scale consists of 11 points, with a score classification from 0 to 10. A score of 0 represents "no pain at all", and 10 means "the worst pain possible". Patients will be asked to rate their anterior knee pain intensity levels based on the past fifteen days. The minimum clinically important difference for improvement will be a decrease of 1 point on the scale.

  Evaluations will occur at five time frames: 24 hours before the first treatment session, after the 4th and 6th weeks of treatment, and 6 months and 1 year after the last session.

Secondary Outcomes (8)

• Anterior Knee Pain Scale

  24 hours before the first treatment session, after the 4th and 6th weeks of treatment, and 6 months and 1 year after the last session.

• Tampa Scale for Kinesiophobia

  24 hours before the first treatment session, after the 4th and 6th weeks of treatment, and 6 months and 1 year after the last session.

• Pain Self-Efficacy Questionnaire

  24 hours before the first treatment session, after the 4th and 6th weeks of treatment, and 6 months and 1 year after the last session.

• Chronic Pain Self-Efficacy Scale

  24 hours before the first treatment session, after the 4th and 6th weeks of treatment, and 6 months and 1 year after the last session.

• Pain Catastrophizing Scale

  24 hours before the first treatment session, after the 4th and 6th weeks of treatment, and 6 months and 1 year after the last session.

Study Arms (2)

Strengthening 2 times per week

EXPERIMENTAL

This group will consist of participants with patellofemoral pain and will receive treatment twice a week.

Other: Strengthening 2 times per week

Strengthening 3 times per week

OTHER

This group will consist of participants with patellofemoral pain and will receive treatment twice a week.

Other: Strengthening 3 times per week

Interventions

Strengthening 2 times per week OTHER

This group will consist of participants with patellofemoral pain and will receive treatment twice a week.

Strengthening 2 times per week

Strengthening 3 times per week OTHER

This group will consist of participants with patellofemoral pain and will receive treatment thrice a week.

Strengthening 3 times per week

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, São Paulo, 01.504-001, Brazil

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• PAULO RG LUCARELI, PhD

  Nove de Julho University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Human Movement Analysis Laboratory

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 5, 2025
• Study Start: February 24, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)